OsteoFab™ Patient Specific Cranial Device Receives 510(k) Approval - OsteoFab™ Implants Ready for US Market and Beyond

Oxford Performance Materials (OPM) is pleased to announce it has received FDA 510(k) clearance Implant made with OPM's OsteoFab Technologyfor the OsteoFab™ Patient Specific Cranial Device (OPSCD). “OsteoFab” is OPM’s brand for Additively Manufactured medical and implant parts produced from PEKK polymer. With OPM’s Additive Manufacturing process (also called “3D Printing”), implants are “grown” layer by layer directly from a digital CAD file without the aid of tooling and with few practical limits on what can be produced. As such, the OsteoFab™ technology is ideal for one-of implants specifically shaped to each patient’s anatomy. One very desirable use of patient specific implants and the indication for the OPSCD is cranial implants to replace bony voids in the skull due to trauma or disease. FDA clearance of this device marks the first approval for an additively manufactured polymer implant.

Source and more:
http://www.oxfordpm.com/news/category/press_releases

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